FDA updates guidance on product development to fight HIV

20 March 2019

The US Food and Drug Administration has announced new final guidance on HIV prevention, following US President Donald Trump’s recently-announced effort to eliminate the HIV epidemic within America.

Guidance on developing products for pre-exposure prophylaxis and developing products for pediatric treatment is being provided to help sponsors with nonclinical and clinical recommendations particular to the development of systemic drug products.

Mr Trump’s HIV initiative comes as the US Centers for Disease Control and Prevention (CDC) issued a new report showing that the rate of HIV infections in the USA has stopped falling.

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